Home NDC 0480-3720 Pyrimethamine
Product NDC 0480-3720
11-digit product format 004803720
Labeler code 0480
Product ID 0480-3720_90ea4054-7c0a-4971-be57-d72e482491b8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pyrimethamine
Dosage form TABLET
Route ORAL
Labeler Teva Pharmaceuticals, Inc.
Application ANDA215506
Marketing category ANDA
Marketing start 2021-12-15
Substance PYRIMETHAMINE
Active strength 25 mg/1
Pharmacologic classes Dihydrofolate Reductase Inhibitor Antimalarial [EPC], Dihydrofolate Reductase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A215506-001 PYRIMETHAMINE PYRIMETHAMINE 25MG TABLET / ORAL AB 2021-08-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215506-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A215506-001 PYRIMETHAMINE 25MG TABLET / ORAL AB 2021-08-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215506-001 PYRIMETHAMINE 25MG TABLET / ORAL AB 2021-08-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215506-001 PYRIMETHAMINE 25MG TABLET / ORAL AB 2021-08-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215506-001 PYRIMETHAMINE 25MG TABLET / ORAL AB 2021-08-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215506-001 PYRIMETHAMINE 25MG TABLET / ORAL AB 2021-08-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215506-001 PYRIMETHAMINE 25MG TABLET / ORAL AB 2021-08-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215506-001 PYRIMETHAMINE 25MG TABLET / ORAL AB 2021-08-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215506-001 PYRIMETHAMINE 25MG TABLET / ORAL AB 2021-08-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215506-001 PYRIMETHAMINE 25MG TABLET / ORAL AB 2021-08-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215506-001 PYRIMETHAMINE 25MG TABLET / ORAL AB 2021-08-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215506-001 PYRIMETHAMINE 25MG TABLET / ORAL AB 2021-08-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215506-001 PYRIMETHAMINE 25MG TABLET / ORAL AB 2021-08-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215506-001 PYRIMETHAMINE 25MG TABLET / ORAL AB 2021-08-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215506-001 PYRIMETHAMINE 25MG TABLET / ORAL AB 2021-08-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A215506-001 PYRIMETHAMINE 25MG TABLET / ORAL AB 2021-08-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A215506-001 PYRIMETHAMINE 25MG TABLET / ORAL AB 2021-08-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A215506-001 PYRIMETHAMINE 25MG TABLET / ORAL AB 2021-08-13 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A215506-001 PYRIMETHAMINE 25MG TABLET / ORAL AB 2021-08-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A215506-001 PYRIMETHAMINE 25MG TABLET / ORAL AB 2021-08-13 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215506-001 PYRIMETHAMINE 25MG TABLET / ORAL AB 2021-08-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215506-001 PYRIMETHAMINE 25MG TABLET / ORAL AB 2021-08-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215506-001 PYRIMETHAMINE 25MG TABLET / ORAL AB 2021-08-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215506-001 PYRIMETHAMINE 25MG TABLET / ORAL AB 2021-08-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215506-001 PYRIMETHAMINE 25MG TABLET / ORAL AB 2021-08-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215506-001 PYRIMETHAMINE 25MG TABLET / ORAL AB 2021-08-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A215506-001 PYRIMETHAMINE 25MG TABLET / ORAL AB 2021-08-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A215506-001 PYRIMETHAMINE 25MG TABLET / ORAL AB 2021-08-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A215506-001 PYRIMETHAMINE 25MG TABLET / ORAL AB 2021-08-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A215506-001 PYRIMETHAMINE 25MG TABLET / ORAL AB 2021-08-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A215506-001 PYRIMETHAMINE 25MG TABLET / ORAL AB 2021-08-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A215506-001 PYRIMETHAMINE 25MG TABLET / ORAL AB 2021-08-13 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A215506-001 PYRIMETHAMINE 25MG TABLET / ORAL AB 2021-08-13 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215506-001 PYRIMETHAMINE 25MG TABLET / ORAL AB 2021-08-13 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Pyrimethamine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PYRIMETHAMINE 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination Z3614QOX8W Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198182 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0480-3720-01 Pyrimethamine 100 in 1 BOTTLE, PLASTIC TABLET 100 2 0480-3720-56 Pyrimethamine 30 in 1 BOTTLE, PLASTIC TABLET 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0480-3720 PYRIMETHAMINE TABLET [TEVA PHARMACEUTICALS, INC.] 2 Current NDC, Legacy NDC, 2 package rows 20211216_2c57a992-619b-40ce-9395-f12ac47a2c67.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0480-3720-01 00480372001 100 TABLET in 1 BOTTLE, PLASTIC (0480-3720-01) 100 tablet 2021-12-15 0000-00-00 No No Current 0480-3720-56 00480372056 30 TABLET in 1 BOTTLE, PLASTIC (0480-3720-56) 30 tablet 2021-12-15 0000-00-00 No No Current